Extracorporeal shockwave treatment (ESWT) is an extra-corporeal treatment modality for a variety of applications including disintegration of urinary tract calculi, disintegration of any stone-like concretions or depositions of minerals and salts found in ducts, blood vessels or hollow organs of a patient's body, advancing bone union by causing micro-fractures and relieving pain associated with tendons, joints and bony structures. A shockwave device is a device used to perform ESWT, which includes a shockwave source typically comprising an electrical-to-shockwave energy converter and a focusing mechanism for directing shockwaves energy to treated area. Electro-hydraulic, electromagnetic and piezo-electric are some of the technologies utilized for energy conversion while focusing is accomplished via acoustic lenses or via ellipsoidal, parabolic or other shaped reflector. Typically, a shockwave focusing mechanism is cylindrically symmetric about an axis defining the shockwave propagation axis.
One well-known example of ESWT is extracorporeal shockwave lithotripsy (ESWL), which is an extra-corporeal treatment modality for disintegration of calculi, such as kidney stones, stone-like concretions in ducts or hollow organs, and other brittle deposits in the body. A lithotripter is a device used to perform ESWL, which includes a shockwave head coupled to a patient's body, in order to deliver shockwave energy to disintegrate the calculi.
The prior art may be classified according to the geometry of the acoustic wave generation and associated focusing: point source and ellipsoidal reflector, planar source and acoustic lens, cylindrical source and parabolic reflector, and spherical source with no additional focusing. The prior art typically converts electrical energy into acoustic waves, such as by generating a strong pulse of an electric or magnetic field, usually by a capacitor discharge, and then converting the electromagnetic field into acoustic energy.
Point sources for the generation of acoustic waves in a lithotripter are described in various patents, such as U.S. Pat. Nos. 3,942,531 and 4,539,989, for example, the disclosures of which are incorporated herein by reference. A point source typically comprises electrohydraulic apparatus. Fast discharges of electrical energy between tips of closely spaced electrodes give rise to a sequence of spherical waves in a propagating liquid. The electrodes are arranged with respect to an ellipsoidal reflector, which has two focal points. The electrical energy is discharged at the first focus, and the waves are focused onto the second focus.
A planar source typically comprises electromagnetic apparatus. A thin circular membrane applies pressure to the propagation liquid by being jolted or repelled away from a planar coil. Fast discharges of electrical energy into the coil and the associated rapid changes in the magnetic field induce currents in the membrane, turning it into a magnet with a polarization opposite to that of the coil. The ensuing repulsions of the membrane, which is in close contact with the propagating liquid, generate the acoustic waves. U.S. Pat. No. 4,674,505, the disclosure of which is incorporated herein by reference, describes an example of such a planar source with an associated acoustic lens.
Apparatus incorporating a cylindrical source uses an electromagnetic approach similar to that used for the planar source. A coil is mounted on a cylindrical support and a cylindrical membrane, being pushed or repelled radially, gives rise to outwardly propagating cylindrical waves. A parabolic reflector focuses the waves into a point on the cylindrical axis of the system. Cylindrical sources enable using an in-line ultrasonic probe for imaging the focal area. Examples of cylindrical sources are described in U.S. Pat. No. 5,058,569 to Hasssler et al., assigned to Siemens Aktiengesellschaft (Munich, Germany) and U.S. Pat. No. 5,174,280 to Gruenwald et al., assigned to Dornier Medizintechnik GmbH (Germering, Germany), the disclosures of which are incorporated herein by reference.
Spherical waves are generated by an array of piezo-electric transducers or by an electromagnetic approach with a spherical membrane being repulsed inwardly into the propagating liquid. No further focusing is required. Spherical sources are mentioned in the background of U.S. Pat. No. 5,174,280.
Each of the prior art acoustic wave generation and focusing apparatus has limitations. Acoustic wave generators generate shocks at a rate of one or two shocks per second, whereas extracorporeal shockwave treatment (ESWT) typically requires thousands of shocks per treatment. The electrohydraulic approach suffers from the disadvantages of non-uniform discharges, pain and high noise level. The electromagnetic planar approach suffers from the disadvantages of high cost and complexity in manufacturing the coil and lens assembly. Acoustic lenses for planar sources are fragile and non-effective for large apertures. In addition to the complexity of manufacturing electromagnetic cylindrical sources, the parabolic reflector is not highly efficient because the source is in the way of reflected waves adjacent thereto. The piezo-electric array is expensive to manufacture, and it is difficult to obtain high-level, well-distributed intensities. The array requires a relatively large aperture that prevents access for x-ray imaging of the focal area.